1. Field of the Invention
This invention relates to a fluorosis-free ingestible fluoride ion-containing composition useful as a dietary supplement for use alone or as an additive to milk, baby formula or other beverages or foods for users of all ages, particularly infants and young children.
2. Description of the Prior Art
In U.S. Pat. Nos. 4,859,467 and 4,861,590 there are disclosed a fluoride ion-containing compositions which provide a slow release combination to avoid gastrointestinal discomfiture from the release of fluoride ion. These patents disclose the use of monofluorophosphate (MFP) with or without the addition of sodium fluoride (NaF) and in conjunction with calcium. These slow release formulations are especially designed for adult use in treating osteoporosis.
Daily dietary supplements of sodium fluoride have been found to be effective in preventing dental decay, but have produced cosmetically objectionable fluorosis (mottling) on anterior upper incisor teeth as set forth in "Effects of Fluoride Supplementation from Birth on Human Deciduous and Permanent Teeth," Aasenden, Roland Peebles, TC, Arch Oral Biol 19, 1974. As a result, in 1979, The American Dental Association and the American Academy of Pediatrics recommended a fifty percent reduction in the daily dose for children under two years old. The new dosage established at that time became 0.25 mg fluoride ion (from 0.55 mg sodium fluoride). As a result, the dosage age schedule is more closely related to changes in body weight during infancy and childhood. See American Academy of Pediatrics, Committee on Nutrition: Fluoride supplementation, "Revised Dosage Schedule," Pediatrics 63, 1979.
However, there is still concern about the rate of fluoride dosing because animal studies have shown that "peak" blood fluoride levels, above the therapeutic range, can produce fluorosis. Therefore, in order to avoid peak levels, it is desirable to modify the conventional once a day dosing into divided doses, as occurs naturally with fluoridated drinking water. Alternatively, the use of a slow-release composition once daily is more convenient to administer as set forth in U.S. Pat. Nos. 4,859,467 and 4,861,590. However, the latter relate to compositions especially adapted for adults for use in ameliorating osteoporosis and are not specific with regard to mixtures of sodium monofluorophosphate and sodium fluoride which provide fluorosis-free advantage upon ingestion.
The fluorosis-free composition of the present invention is distinct from non-ingested oral treatment compositions containing binary fluoride sources of sodium fluoride and sodium monofluorophosphate such as are described in U.S. Pat. Nos. 4,152,419, 4,425,324 and 4,528,181, as well as British Patent No. 1 435 624.